Some women have experienced some distressing side effects and we are working closely with surgeons and the MHRA to make sure that improvements are made and patients are well informed...
(PRWEB) November 29, 2012
Public Health Watchdog, a media outlet created to protect and warn consumers about the dangers of defective drugs and medical devices, is informing the public about a recent update issued by health regulators in the United Kingdom. According to a media release by the Department of Health, National Health Service (NHS) Commissioning Board and the Medicines and Healthcare products Regulatory Agency (MHRA), surgeons in the UK will have better information on how to reduce the risk of complications associated with transvaginal mesh implants used to treat pelvic organ prolapse.
According to the Department of Health, roughly 15 percent of women report adverse events related to receiving mesh implants for pelvic organ prolapse, a condition that causes pelvic organs to slip out of place due to the weakening of the pelvic muscles. New measures are now being implemented in response to a number of women who report serious injuries after receiving a mesh implant. “These measures will include developing proposals for a registry for implanted vaginal tapes and meshes to help surgeons to compare the outcomes of their treatment, building on the voluntary registries already established by the professional associations.”
Professor Keith Willett, National Clinical Director for Acute Episodes of Care at the NHS Commissioning Board, stated that “Some women have experienced some distressing side effects and we are working closely with surgeons and the MHRA to make sure that improvements are made and patients are well informed about the benefits and potential risks with these procedures.”
In the US, transvaginal mesh implants are approved to treat pelvic organ prolapse and stress urinary incontinence. The U.S. Food and Drug Administration (FDA) has addressed numerous reports of complications linked to the device, such as:
- Mesh erosion through the vagina (exposure, extrusion, protrusion)
- Pain during sexual intercourse (dyspareunia)
- Organ perforation
- Urinary problems
In a Safety Communication issued last year, the agency warned that these side effects are “not rare” and cautioned that there is no clear advantage to using mesh implants over non-mesh methods for treating pelvic organ prolapse. The FDA has also asked transvaginal manufacturers to conduct post-market safety studies on the adverse effects associated with the devices.
Earlier this year, Johnson & Johnson stated that they would no longer sell the Prolift, Prolift + M, TVT Secur and Prosima transvaginal mesh.
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